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The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.

The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.

The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).

The provided text describes a 510(k) submission for a Digital Electrocardiograph, models iE101 and iE300. The submission argues for substantial equivalence to a predicate device (K141946).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria for diagnostic accuracy. The "acceptance criteria" here are essentially the compliance with relevant safety and performance standards and the demonstration that the proposed device performs similarly to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set in the context of clinical performance evaluation based on patient data. The "tests" conducted were non-clinical, likely bench testing and engineering verification to demonstrate compliance with standards.

• Sample Size for Test Set: Not applicable as no clinical test set was used.
• Data Provenance: Not applicable as no clinical data was used for a test set. The non-clinical tests were conducted by the manufacturer (Shenzhen Biocare Bio-medical Equipment Co., Ltd.) in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical study or test set requiring expert-established ground truth was performed for this submission. The device's "analysis feature" is offered on an advisory basis only, meaning its interpretive statements are not intended as definitive diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as no clinical study or test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states "No clinical study is included in this submission." Therefore, no MRMC study was conducted, and no effect size calculation for human readers with or without AI assistance is available.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device has an "analysis feature," the submission does not include any standalone performance study of this algorithm. The analysis feature provides "measurements and interpretive statements" on an "advisory basis only," indicating it's not cleared for diagnostic standalone use.

7. The Type of Ground Truth Used

Not applicable, as no clinical performance study requiring ground truth was conducted. For non-clinical tests (electrical safety, EMC, etc.), the "ground truth" would be the specifications and requirements of the relevant IEC standards.

8. The Sample Size for the Training Set

Not applicable. This device is an electrocardiograph hardware with an accompanying analysis feature. The submission does not describe a machine learning algorithm that underwent training with a specific dataset. The analysis function is likely based on pre-programmed algorithms rather than a trained AI model in the modern sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no described training set or AI model training in the submission.

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Digital Electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

The provided document is a 510(k) premarket notification for a Digital Electrocardiograph, Model: ECG-2000. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets acceptance criteria derived from a novel clinical trial.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, accuracy, etc. Instead, it demonstrates compliance with technical specifications and safety standards to establish substantial equivalence. The "performance" reported is primarily in terms of meeting these engineering and safety benchmarks.

| Feature | Predicate Device 1 (K092010)
Description / Value | Proposed Device (ECG-2000)
Reported Performance |
|-----------------------|----------------------------------------------------|---------------------------------------------------|
| Product Code | DPS | DPS (Same) |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 (Same) |
| Class | Class II | Class II (Same) |
| Intended Use | Acquire ECG signals from adult patients to help analyze and diagnose heart disease. Used by healthcare professionals. | Acquire ECG signals from adult and pediatric patients to help analyze and diagnose heart disease. Used by healthcare professionals. (Similar: extended to pediatric patients)|
| Configuration | Chest Electrode and Limb Electrode | Chest Electrode and Limb Electrode (Same) |
| ECG Lead | Standard 12-lead | Standard 12-lead (Same) |
| ECG Gain | (Implied range from "Similar" to proposed device) | 1.25, 2.5, 5, 10, 20, 10-5, 20-10 (mm/mV) (More options than Predicate 1, Same as Predicate 2) |
| Sampling rate | 1000Hz | 1000Hz (Same) |
| Input circuit current | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $\leq$ 0.1 μA (Complies with IEC 60601-1) |
| Noise level | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $

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The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.

The CardioPro analysis program is the analysis program used in this proposed device.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity regarding the analysis and diagnosis of heart disease. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and compliance with international safety and performance standards.

The table below summarizes the technical specifications and standards compliance, which implicitly serve as performance requirements for the device's functionality.

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Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

The provided text is a 510(k) summary for a Digital Electrocardiograph (ECG-2000) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications. It does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe such a study.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and complied with relevant IEC and EN standards for electrical safety, EMC, and particular requirements for electrocardiographs. It also mentions "Software Verification Test was performed to verify the software functions against its intended use." However, these are engineering verification tests, not clinical performance studies for diagnostic accuracy.

The closest to "acceptance criteria" presented in the document are the technical specifications compared with predicate devices, such as:

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Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

The provided text is a 510(k) summary for Digital Electrocardiographs (models iE 3, iE 6) and a letter from the FDA determining their substantial equivalence to a predicate device (iE 12). This document does not contain information about specific acceptance criteria, device performance metrics, or details of a study demonstrating the device meets such criteria.

The core of this document is a comparison between the proposed devices and a predicate device to establish "substantial equivalence," meaning that the new devices are as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical study demonstrating performance against specific benchmarks.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or directly stated from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The acceptance criteria, in the context of this 510(k), are primarily related to meeting design specifications and demonstrating substantial equivalence to the predicate device, especially regarding safety and intended use.
• Reported Device Performance: No specific numerical performance metrics are reported in this document. The document states a "Non-Clinical Test Conclusion" that "Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1, IEC 60601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance for diagnosing heart disease.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not mentioned, as a clinical study with ground truth established by experts is not detailed here.

4. Adjudication Method

• Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• If done: No, an MRMC comparative effectiveness study is not described or referenced in this document. This submission focuses on establishing substantial equivalence to a predicate device based on technical characteristics and intended use, not on demonstrating improved human reader performance with AI assistance.
• Effect size of human readers improvement: Not applicable, as no such study is presented.

6. Standalone (Algorithm Only) Performance Study

• If done: No, a standalone performance study of an algorithm is not described or referenced. The device is a "Digital Electrocardiograph" which acquires, displays, and records ECG signals for users (doctors/trained professionals) to analyze and diagnose. While it "can help users to analyze and diagnose heart disease," the document does not detail an inherent diagnostic algorithm's performance.

7. Type of Ground Truth Used

• Not mentioned, as no clinical study requiring a ground truth is detailed.

8. Sample Size for the Training Set

• Not mentioned, as this document does not describe the development or training of an AI algorithm.

9. How Ground Truth for the Training Set Was Established

• Not mentioned, as this document does not describe the development or training of an AI algorithm.

Summary of what the document does provide:

• Device Models: iE 3, iE 6
• Intended Use: To acquire ECG signals from adult and pediatric patients through body surface ECG electrodes, with obtained records helping users to analyze and diagnose heart disease. To be used in healthcare facilities by doctors and/or trained healthcare professionals.
• Predicate Device: Digital Electrocardiographs, iE 12 (K122712)
• Regulatory Basis for Acceptance: Substantial Equivalence (SE) to the predicate device, demonstrated through non-clinical tests verifying compliance with design specifications and international safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
• Key Comparison Points for SE: Intended use, technological characteristics, principles of operation, patient contact material, sterile/single use status, energy source, safety standards, and accessories are deemed equivalent to the predicate device.

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